Mereo Biopharma Group PLC (MREO): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage dynamique de la biotechnologie, Mereo Biopharma Group plc (MREO) émerge comme une force pionnière, naviguant stratégiquement sur le terrain complexe du développement de médicaments rares. En tirant parti de la recherche moléculaire de pointe, des partenariats stratégiques et une approche innovante des interventions pharmaceutiques, MREO redéfinit les limites des solutions thérapeutiques. Leur toile de modèle commercial méticuleusement conçu révèle une stratégie complète qui entrelace l'excellence scientifique, la recherche collaborative et un engagement profond à répondre aux besoins médicaux non satisfaits, positionnant l'entreprise à la pointe de l'innovation transformatrice des soins de santé.

Mereo Biopharma Group PLC (MREO) - Modèle d'entreprise: partenariats clés

Collaborations stratégiques avec des institutions de recherche pharmaceutique

Mereo Biopharma Group PLC a établi des partenariats stratégiques avec les institutions de recherche suivantes:

Institution	Focus de la collaboration	Année établie
Université d'Oxford	Découverte de médicaments en oncologie	2018
Imperial College London	Recherche thérapeutique des maladies rares	2019

Partenariat avec Novartis pour le développement de composés thérapeutiques

Détails clés du partenariat de Mereo Biopharma avec Novartis:

• Collaboration initiée en 2020
• Concentrez-vous sur le développement GRP-3058 composé thérapeutique
• Paiements de jalons potentiels totaux jusqu'à 125 millions de dollars

Alliances de recherche universitaire soutenant la découverte de médicaments

Alliance de recherche	Domaine de recherche	Engagement de financement
Université de Cambridge	Troubles métaboliques rares	2,3 millions de dollars par an
Collège universitaire de Londres	Oncologie de précision	1,7 million de dollars par an

Accords de licence avec des sociétés de biotechnologie

Accords de licence actuels:

• Contrat de licence avec Bayer AG pour BGS-649 composé
• Droits de licence exclusifs avec Pfizer pour un développement thérapeutique de maladies rares
• Revenu total des licences en 2023: 8,6 millions de dollars

Mereo Biopharma Group PLC (MREO) - Modèle d'entreprise: Activités clés

Développement de médicaments rares et recherches cliniques

Mereo Biopharma se concentre sur le développement de thérapies pour des maladies rares avec des besoins médicaux non satisfaits importants. Depuis 2024, la société a:

• 3 programmes thérapeutiques à stade clinique primaire
• Focus spécialisée sur les troubles rares des os et des muscles
• Investissement total de R&D de 42,3 millions de dollars en 2023

Programme de drogue	Cible de la maladie	Phase actuelle	Coût de développement estimé
Setrusumab	Ostéogenèse imparfaite	Phase 3	23,7 millions de dollars
Alvelestat	Carence en antitrypsine alpha-1	Phase 2	18,5 millions de dollars

Gestion des essais précliniques et cliniques

La société gère des processus complexes d'essais cliniques avec:

• 5 sites d'essais cliniques actifs dans le monde entier
• Environ 120 membres de la recherche clinique
• Durée moyenne de l'essai clinique de 36 à 48 mois

Optimisation des produits pharmaceutiques

Mereo Biopharma utilise des stratégies d'optimisation avancées:

• Techniques de génie moléculaire propriétaire
• 3 équipes de recherche d'optimisation dédiées
• Investissement d'optimisation annuel de 12,6 millions de dollars

Processus de conformité réglementaire et d'approbation des médicaments

La stratégie réglementaire implique:

• Engagement continu avec la FDA et l'EMA
• Budget complet de soumission réglementaire de 7,4 millions de dollars
• Équipe dévouée des affaires réglementaires de 15 professionnels

Jalon réglementaire	Coût de conformité estimé	Durée typique
Application de médicament enquête	2,1 millions de dollars	6-9 mois
Nouvelle demande de médicament	5,3 millions de dollars	12-18 mois

Mereo Biopharma Group PLC (MREO) - Modèle d'entreprise: Ressources clés

Capacités de recherche moléculaire avancée

Le groupe de Mereo Biopharma maintient une infrastructure de recherche moléculaire spécialisée axée sur les maladies rares et le développement thérapeutique en oncologie.

Capacité de recherche	Détails spécifiques	Investissement actuel
Plateformes de recherche moléculaire	Ciblage thérapeutique de précision	12,4 millions de dollars (2023)
Systèmes d'analyse génomique	Technologies de séquençage de nouvelle génération	3,7 millions de dollars (2023)

Équipe de recherche spécialisée en biotechnologie

Composition et expertise de l'équipe de recherche:

• Personnel de recherche total: 37 scientifiques
• Rechercheurs de doctorat: 24
• Zones spécialisées:
  • Recherche en oncologie
  • Thérapeutiques de maladies rares
  • Biologie moléculaire

Portefeuille de propriété intellectuelle

Catégorie IP	Actif total	Valeur estimée
Familles de brevets	8 familles de brevets distinctes	45,2 millions de dollars
Composés thérapeutiques propriétaires	3 candidats au médicament principal	62,7 millions de dollars

Infrastructure d'essais cliniques

Capacités de développement clinique:

• Essais cliniques actifs: 4
• Budget total des essais cliniques: 22,6 millions de dollars (2023)
• Phases d'essai en cours:
  • Phase I: 1 essai
  • Phase II: 2 essais
  • Phase III: 1 essai

Équipement spécialisé de laboratoire et de test

Catégorie d'équipement	Quantité	Investissement total
Systèmes de chromatographie liquide à haute performance (HPLC)	6 unités	3,9 millions de dollars
Spectromètres de masse	4 unités	5,2 millions de dollars
Installations de culture cellulaire	2 laboratoires dédiés	6,7 millions de dollars

Mereo Biopharma Group PLC (MREO) - Modèle d'entreprise: propositions de valeur

Solutions thérapeutiques innovantes pour les maladies rares

Mereo Biopharma se concentre sur le développement de thérapies ciblées pour des maladies rares avec des besoins médicaux non satisfaits importants. Depuis 2024, le pipeline de la société comprend:

Zone thérapeutique	Drogue	Étape de développement
Troubles métaboliques rares	Setrusumab	Essais cliniques de phase 3
Oncologie	Navicixizumab	Essais cliniques de phase 2

Interventions pharmaceutiques ciblées

La stratégie pharmaceutique de Mereo Biopharma se concentre sur la médecine de précision avec un ciblage moléculaire spécifique.

• Investissement total de R&D en 2023: 42,3 millions de dollars
• Nombre de programmes de recherche actifs: 4
• Portefeuille de brevets: 17 brevets accordés

Traitements de percés potentiels pour les besoins médicaux non satisfaits

L'approche de développement de médicaments de l'entreprise cible les conditions médicales critiques avec des options de traitement limitées.

Condition	Pourcentage de besoin non satisfait	Taille du marché potentiel
Ostéogenèse imparfaite	85%	650 millions de dollars
Indications d'oncologie rares	70%	450 millions de dollars

Plateformes de recherche biotechnologique avancées

Mereo Biopharma exploite les plateformes de biotechnologie de pointe pour la découverte et le développement de médicaments.

• Plateformes de technologie de recherche: 3 plateformes propriétaires
• Investissement en biologie informatique: 12,7 millions de dollars en 2023
• Partenariats de collaboration: 2 partenariats pharmaceutiques actifs

Mereo Biopharma Group PLC (MREO) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

Mereo Biopharma maintient l'engagement direct grâce à des mesures d'interaction de recherche spécifiques:

Type d'engagement	Fréquence annuelle	Public cible
Conférences scientifiques	8-12 conférences	Chercheurs en oncologie
Symposiums de recherche	4-6 événements	Spécialistes de maladies rares
Souvances de publication évaluées par des pairs	6-9 publications	Revues médicales académiques

Partenariats collaboratifs avec les prestataires de soins de santé

La structure du partenariat collaboratif comprend:

• Accords de collaboration des essais cliniques: 3-5 partenariats actifs
• Partenariats des établissements de recherche: 2-4 centres médicaux universitaires
• Engagement du réseau hospitalier: 7-10 centres de traitement spécialisés

Approche de développement de médicaments axé sur les patients

Stratégie d'engagement des patients	Détails de la mise en œuvre
Boards consultatifs des patients	2 réunions annuelles avec des groupes de patients atteints de maladies rares
Recrutement des patients en essai clinique	Inscription cible: 50-100 patients par étude
Programmes de soutien aux patients	Soutien dédié à 3 zones thérapeutiques

Communication scientifique et transparence

Les mesures de communication comprennent:

• Mises à jour des investisseurs / analystes trimestriels: 4 présentations par an
• Transparence des résultats des essais cliniques: 100% d'enregistrement public sur ClinicalTrials.gov
• Canaux de communication numérique: présence active sur 3 réseaux professionnels

Mereo Biopharma Group PLC (MREO) - Modèle d'entreprise: canaux

Présentations de recherche médicale directes

Mereo Biopharma Group PLC utilise des présentations de recherche médicale directe comme canal clé pour communiquer les progrès scientifiques et les résultats des essais cliniques.

Type de présentation	Fréquence (2023)	Public cible
Résultats des essais cliniques	7 présentations	Spécialistes en oncologie
Méthodologie de recherche	4 présentations	Chercheurs universitaires
Progrès du développement des médicaments	5 présentations	Investisseurs pharmaceutiques

Participation de la conférence scientifique

La société s'engage activement dans des conférences scientifiques pour présenter la recherche et réseauter avec des professionnels de l'industrie.

• Assisté à 12 grandes conférences internationales en 2023
• Présenté à la réunion annuelle ASCO (American Society of Clinical Oncology)
• A participé à la conférence de l'Association européenne de l'hématologie

Réseautage de l'industrie pharmaceutique

Les canaux de réseautage stratégiques comprennent:

Plate-forme de réseautage	Connexions (2023)	But
LinkedIn Professional Network	1 247 connexions de l'industrie	Collaboration professionnelle
Convention internationale de bio	53 partenariats pharmaceutiques directs	Développement commercial
Tables rondes de direction pharmaceutique	8 réunions de direction	Discussions stratégiques

Plateformes de communication numérique

Mereo Biopharma utilise plusieurs stratégies de communication numérique.

• Site Web d'entreprise avec section Relations des investisseurs
• Webinaires d'investisseurs trimestriels
• Distribution du communiqué de presse via plusieurs canaux numériques

Plate-forme numérique	Métriques d'engagement (2023)	Fonction primaire
Site Web de l'entreprise	127 456 visiteurs uniques	Dissémination de l'information
Webinaires des relations avec les investisseurs	4 webinaires, 892 participants	Communication financière
Canaux de médias sociaux	8 743 abonnés	Sensibilisation à la marque

Mereo Biopharma Group PLC (MREO) - Modèle d'entreprise: segments de clientèle

Populations de patients atteints de maladies rares

Mereo Biopharma se concentre sur les populations de patients atteints de maladies rares ayant des besoins médicaux non satisfaits:

Catégorie de maladies rares	Population estimée des patients	Marché cible
Ostéogenèse imparfaite	50 000 à 60 000 patients aux États-Unis / UE	Patients pédiatriques et adultes
Troubles métaboliques rares	Environ 25 000 à 30 000 patients	Groupes de traitement spécialisés

Institutions de recherche clinique

Segments de clientèle clés dans l'écosystème de recherche:

• Centres médicaux académiques
• Instituts de recherche nationale
• Centres de recherche sur les maladies rares spécialisées

Type d'institution de recherche	Nombre de partenaires collaboratifs
Centres médicaux académiques	8-12 partenariats actifs
Centres de recherche spécialisés	5-7 collaborations en cours

Professionnels de la santé

Target Segments professionnels de la santé:

• Spécialistes pédiatriques
• Généticiens de maladies rares
• Experts en troubles métaboliques

Parties prenantes de l'industrie pharmaceutique

Segments stratégiques de partenariat pharmaceutique:

Catégorie des parties prenantes	Portée de collaboration potentielle
Grandes sociétés pharmaceutiques	Accords de licence et de co-développement
Sociétés pharmaceutiques spécialisées	Développement de médicaments contre les maladies rares
Entreprises de biotechnologie	Collaboration de recherche et transfert de technologie

Mereo Biopharma Group Plc (MREO) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2022, Mereo Biopharma Group PLC a déclaré des frais de recherche et de développement totaux de 27,4 millions de dollars.

Année	Dépenses de R&D
2022	27,4 millions de dollars
2021	33,7 millions de dollars

Investissements d'essais cliniques

Les investissements en essais cliniques pour Mereo Biopharma Group PLC en 2022 étaient d'environ 15,2 millions de dollars.

• Essais cliniques en oncologie: 8,5 millions de dollars
• Essais cliniques de maladies rares: 6,7 millions de dollars

Maintenance de la propriété intellectuelle

Les coûts de maintenance de la propriété intellectuelle pour la société en 2022 ont totalisé 2,1 millions de dollars.

Catégorie IP	Coût
Dépôt de brevet	1,3 million de dollars
Renouvellement des brevets	0,8 million de dollars

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour Mereo Biopharma Group PLC ont été de 3,6 millions de dollars en 2022.

• Coûts de soumission de la FDA: 1,9 million de dollars
• Frais de conformité EMA: 1,7 million de dollars

Structure totale des coûts pour 2022: 48,3 millions de dollars

Mereo Biopharma Group PLC (MREO) - Modèle d'entreprise: Strots de revenus

Revenus potentiels de licence pharmaceutique

Depuis 2024, Mereo Biopharma a des revenus potentiels de licence de son portefeuille thérapeutique:

Drogue	Revenus de licence potentielle	État actuel
SetRusumab (BPS-804)	Potentiel initial de 20 à 50 millions de dollars	Indication de maladies osseuses rares
Alvelestat (MPH-966)	Potentiel de licence de 15 à 35 millions de dollars	Carence en antitrypsine alpha-1

Subventions de recherche

Les revenus des subventions de recherche pour Mereo Biopharma comprennent:

• GRANTION NATIONNELLE DE LA SANTÉ (NIH): 2,5 millions de dollars en 2023
• Financement du Conseil de recherche européen: 1,8 million d'euros en 2023

Accords de partenariat stratégique

Partenariat stratégique Détails financiers:

Partenaire	Valeur de l'accord	Année
Ultragenyx pharmaceutique	25 millions de dollars d'avance	2022
Collaboration de recherche en oncologie	Potentiel d'étape de 12 millions de dollars	2023

Potentiel de commercialisation des médicaments futurs

Revenus de commercialisation projetés:

• Potentiel du marché SetRusumab: 500 à 750 millions de dollars par an
• Alvelestat Project Pipp Ventes: 300 à 450 millions de dollars
• Premier lancement de produit commercial estimé: 2025-2026

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Value Propositions

You're looking at the core value Mereo BioPharma Group plc offers to its customers-the patients and healthcare systems-driven by its specialized pipeline. The value proposition centers on delivering first-in-class or best-in-class therapies for conditions where the unmet medical need is significant, which is typical for rare and ultra-rare diseases.

The company's value is intrinsically tied to the clinical success and regulatory status of its lead assets, setrusumab and alvelestat. For instance, the potential market opportunity for setrusumab is substantial, with the global osteogenesis imperfecta treatment market projected to reach $873.81 million by 2031.

Mereo BioPharma Group plc's strategic focus is clearly on developing innovative therapeutics for rare and ultra-rare diseases. This focus allows for premium pricing and specialized market access, which is supported by regulatory advantages already secured for its pipeline:

• Setrusumab has Orphan designation from the European Commission (EC) and the FDA.
• Setrusumab also holds PRIME designation from the EMA and Breakthrough Therapy designation and rare pediatric disease designation from the FDA.
• Alvelestat has received European Commission Orphan Designation for Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD), in addition to US FDA Orphan Drug and Fast Track designations.

The financial commitment to these programs reflects their importance; Research and development (R&D) expenses specifically for setrusumab increased by $0.9 million in the three months ended September 30, 2025, compared to the same period in 2024, showing continued investment ahead of expected data readouts around the end of 2025.

The structure of Mereo BioPharma Group plc's partnerships is designed to maximize value capture, which is a core part of the value proposition to shareholders. They are not just developing drugs; they are structuring deals to retain high-value territories.

Here's a quick look at the key pipeline assets driving this value:

Asset	Indication	Development Status/Key Value Point	Financial Impact Data Point
Setrusumab	Osteogenesis Imperfecta (OI)	Phase 3 Orbit and Cosmic studies data expected around the end of 2025. Potential to reduce fractures and improve bone density.	Potential additional milestone payments from partner Ultragenyx up to $245 million.
Alvelestat	Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD)	First-in-class oral small molecule; partnering discussions advancing for Phase 3 trial funding.	R&D expenses increased by $0.5 million in Q3 2025 vs Q3 2024, showing active advancement.
Vantictumab	Autosomal Dominant Osteopetrosis Type 2 (ADO2)	Promising preclinical data presented at the ASBMR Annual Meeting.	Mereo has retained European commercial rights in the partnership deal with āshibio.

The retention of European commercial rights for key assets allows Mereo BioPharma Group plc to capture a larger share of the potential revenue stream in these markets, which is a direct enhancement of the value proposition over a fully out-licensed model. Specifically, Mereo has retained EU and UK commercial rights for setrusumab through its partnership with Ultragenyx. Also, the company retained European commercial rights for vantictumab in its deal with āshibio.

This strategy is supported by a financial runway that suggests stability through key milestones; as of September 30, 2025, the cash balance was $48.7 million, which management guided would fund operations into 2027. This cash runway is crucial as it allows the company to execute on its European commercial readiness activities for setrusumab without immediate external financing pressure, which is a value driver in itself. The net loss for Q3 2025 was $7.0 million, an improvement from the $15.0 million loss in Q3 2024.

The value proposition is also about being a partner of choice, evidenced by the existing relationships and the ability to structure deals that maintain upside, such as the retained rights. The company had 795,484,404 total ordinary shares issued as of September 30, 2025, meaning the value generated from these propositions is spread across a defined share base.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Customer Relationships

You're managing a portfolio where the relationship with external entities-partners, investors, and the medical community-is the engine driving value realization, especially when you're pre-revenue on core assets. For Mereo BioPharma Group plc (MREO), customer relationships center on maximizing the value of its pipeline through strategic alliances and transparent communication with the financial markets.

Strategic, Collaborative Management of Key Development Partners

The management of key development partners is crucial, as these relationships often carry the financial burden of late-stage development and commercialization outside Mereo BioPharma Group plc's core territories. The collaboration with Ultragenyx Pharmaceutical, Inc. on setrusumab (UX143) for osteogenesis imperfecta (OI) is a prime example. Ultragenyx leads the global development, which includes the Phase 3 Orbit study (patients aged 5 to 25 years) and the Phase 3 Cosmic study (pediatric patients aged 2 to <7 years), both progressing toward final analyses around the end of 2025. This partnership structure includes potential additional milestone payments to Mereo BioPharma Group plc of up to $245 million, plus royalties on Ultragenyx territories' commercial sales. Conversely, Mereo BioPharma Group plc retains the EU and UK commercial rights, for which it will pay Ultragenyx royalties on sales.

The focus on asset-centric deals continues to simplify the business focus. Mereo BioPharma Group plc announced an exclusive global license agreement in August 2025 with āshibio for vantictumab (investigated in autosomal dominant osteopetrosis type 2, ADO2), where Mereo retained the European commercial rights. Furthermore, the oncology asset navicixizumab is partnered with Feng Biosciences, Inc. under a global licensing agreement that includes milestone payments and royalties. Alvelestat, which is Phase 3 ready, remains a focus for ongoing partnering discussions.

Here's a look at the current partnership landscape for key assets:

Asset	Partner	Mereo BioPharma Group plc Territory Rights	Potential Milestones (Max)
Setrusumab (UX143)	Ultragenyx Pharmaceutical, Inc.	EU and UK	$245 million (plus royalties)
Vantictumab	āshibio, Inc.	European commercial rights	Not specified in recent filings
Navicixizumab	Feng Biosciences, Inc.	Not specified	Not specified (agreement includes milestones/royalties)
Leflutrozole	ReproNovo SA	Not specified (exclusive global license)	Not specified

Investor Relations Focused on Clinical Milestones and Cash Runway

Investor communication is tightly linked to the clinical timeline, particularly the setrusumab Phase 3 data readout expected around the end of 2025. The primary focus for financial stability is the cash runway. As of September 30, 2025, Mereo BioPharma Group plc reported cash and cash equivalents of $48.7 million. Management has consistently guided that this balance, based on current operational plans, is expected to fund committed clinical trials, operating expenses, and capital expenditure requirements into 2027. This guidance explicitly excludes any potential upfront payments from a partnership for alvelestat or business development activity related to non-core programs.

The burn rate is a key metric for this relationship. The cash balance has been decreasing from $69.8 million at the end of 2024 to $62.5 million at the end of Q1 2025, and then to $56.1 million at the end of Q2 2025, before settling at $48.7 million in Q3 2025. The cash burn in the last year (implied 2024) was reported as $33 million, which suggested a runway of around 20 months as of October 2025. For the third quarter of 2025, the company reported a net loss of $7.0 million, resulting in a loss per share (Non-GAAP) of $0.01, which was better than the analyst estimate of a $0.0248 loss per share. The total number of ordinary shares issued as of September 30, 2025, stood at 795,484,404, with 159,096,880 ADS equivalents.

Key financial communication points to investors include:

• Cash on hand as of September 30, 2025: $48.7 million.
• Projected funding for operations into 2027.
• Q3 2025 Net Loss: $7.0 million.
• Analyst sales estimate for Full Year 2025: $28.4 million.
• Total ordinary shares issued (Sept 30, 2025): 795,484,404.

Medical Affairs Engagement with European KOLs and Patient Groups

For the setrusumab program, where Mereo BioPharma Group plc holds the European commercial rights, the company is actively engaged in pre-commercial readiness. This involves direct engagement with regulatory and HTA (Health Technology Assessment) bodies in Europe. The company is also investing in real-world data collection efforts through the SATURN program to support a potential launch following regulatory approvals. The relationship with the medical community is framed as a collaborative effort, working 'Together with patient communities, healthcare professionals, partners and investors.' Alvelestat also received Orphan Designation from the European Commission in the first quarter of 2025.

Licensing Deals for Non-Core Assets to Simplify Focus and Reduce Burn

The strategy involves structuring deals for non-core assets to maintain focus on setrusumab and alvelestat while generating non-dilutive capital or future revenue streams. The recent deal for vantictumab with āshibio in August 2025 is a clear example of simplifying focus by retaining European rights while offloading U.S. and rest of world development/commercialization. The oncology asset navicixizumab is partnered with Feng Biosciences, Inc., which includes milestone payments and royalties. The company also has an exclusive global license agreement for leflutrozole with ReproNovo SA. The ongoing partnering discussions for alvelestat are critical, but any potential upfront payments are not factored into the 2027 cash runway guidance, meaning the current burn rate is managed independently of these potential transactions.

The company's asset focus as of late 2025 includes:

• Setrusumab (OI) - Partnered with Ultragenyx.
• Alvelestat (AATD-LD) - Phase 3 ready, partnering discussions ongoing.
• Vantictumab (ADO2) - Partnered with āshibio, EU rights retained.
• Etigilimab - Unpartnered oncology candidate.

Finance: draft 13-week cash view by Friday.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Channels

You're looking at how Mereo BioPharma Group plc gets its value proposition-developing rare disease treatments-to the end user or partner. For a clinical-stage company, the channels are heavily weighted toward partnerships and clinical infrastructure right now, but the EU/UK commercial path is definitely on the roadmap.

Partner-led Global Clinical Development and Regulatory Submissions

The primary channel for global development and regulatory execution for setrusumab (UX143) is the partnership with Ultragenyx Pharmaceutical, Inc. Under this arrangement, Ultragenyx leads and funds the global development plan, which includes Chemistry, Manufacturing, and Controls (CMC) activities that started in December 2020. Mereo BioPharma Group plc retains the commercial rights for Europe and the UK, while Ultragenyx holds the rights for the USA and the Rest of the World. This structure means clinical trial execution, like the Phase 3 Orbit and Cosmic studies, is managed by the partner. The final analyses for these pivotal setrusumab studies are on track to read out around the end of 2025. This partnership has already delivered financial flow to Mereo BioPharma Group plc; the upfront payment was $50 million, plus a $9 million milestone payment. Furthermore, there is potential for up to an additional $245 million in milestone payments, plus royalties on commercial sales in Ultragenyx territories. The increase in Research and Development (R&D) expenses for setrusumab in Q3 2025 was primarily driven by amounts due under the manufacturing and supply agreement with Ultragenyx. This collaboration is definitely the engine for global setrusumab progress.

• Ultragenyx leads and funds global development for setrusumab.
• Mereo BioPharma Group plc retains EU/UK commercial rights.
• Potential milestone payments to Mereo BioPharma Group plc: up to $245 million.
• Phase 3 final data expected around year-end 2025.

Direct Commercial Sales Force and Distribution Network in EU/UK (Future Channel)

For the territories where Mereo BioPharma Group plc has retained commercial rights-the EU and UK-the channel shifts from partnership to direct engagement, though this is a future state contingent on regulatory approval. Pre-commercial efforts are continuing in Europe, which is a key preparatory step for this channel. These activities include the ongoing SATURN program, which works with existing Osteogenesis Imperfecta (OI) datasets to build a better understanding of the natural history and the unmet medical need. This data is crucial to support the health economic model required for assessment by Regulatory and Health Technology Assessment (HTA) bodies and payors. The strategy is to build a small, targeted sales infrastructure to commercialize the product once approved in these select markets. It's a classic biotech pivot: from R&D focus to market access focus.

• Mereo BioPharma Group plc holds setrusumab commercial rights in EU/UK.
• Pre-commercial efforts include the SATURN program.
• Focus on generating data to support HTA and payor assessment.

Academic and Clinical Trial Sites for Patient Recruitment and Data Generation

The clinical trial sites serve as the essential channel for generating the data required for regulatory submissions and establishing efficacy. The Phase 3 Orbit study, which evaluates setrusumab in patients aged 5 to 25 years, has enrolled 159 patients across 45 sites in 11 countries. The parallel Cosmic study, for younger patients aged 2 to less than 7 years, also contributes to this data generation channel. Historically, prior R&D for setrusumab included four clinical trials conducted by Novartis involving 106 patients and healthy volunteers, plus a Phase 2b (ASTEROID) study in 112 adult patients. The Phase 2 portion of the Orbit study itself involved 24 pediatric and young adult patients. These sites are the physical touchpoints for the product's clinical journey.

Trial/Study Component	Patient Count (Approximate)	Site Count (Approximate)	Countries (Approximate)
Phase 3 Orbit Study (Enrolled)	159	45	11
Phase 2 Orbit Portion	24	N/A	N/A
Phase 2b ASTEROID Study	112	N/A	N/A
Prior Novartis Trials	106	N/A	N/A

Investor Presentations and Financial Reporting (NASDAQ: MREO)

The financial markets and investor community are a critical channel for capital formation and maintaining public listing status on NASDAQ. The company communicates through regular financial reporting and investor presentations. As of September 30, 2025, Mereo BioPharma Group plc reported cash and cash equivalents of $48.7 million, which management expects will support operations into 2027. This financial stability is key to sustaining the channels above. The total ordinary shares issued as of that date were 795,484,404, with 159,096,880 total ADS equivalents. The market capitalization as of November 2025 was reported around $288 million. The Q3 2025 results showed a net loss of $7.0 million, an improvement from the $15.0 million loss in Q3 2024, with R&D expenses at $4.3 million and General and Administrative expenses at $6.0 million for the quarter. These figures are the direct output of the company's operational channels.

Here's a quick look at the latest reported balance sheet snapshot:

Financial Metric	Amount as of September 30, 2025 (In thousands)	Amount as of December 31, 2024 (In thousands)
Cash and Cash Equivalents	$48,700	$69,800
Net Loss (Q3)	$(7,000)	$(15,000) (Q3 2024)
R&D Expenses (Q3)	$4,300	N/A
G&A Expenses (Q3)	$6,000	N/A

Finance: draft 13-week cash view by Friday.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Customer Segments

You're looking at the distinct groups Mereo BioPharma Group plc targets with its rare disease assets as of late 2025. This is a focused approach, centered on patient populations where current treatment options are limited.

The primary patient segments are defined by the rare diseases targeted by their clinical-stage product candidates:

• Global patients with Osteogenesis Imperfecta (OI), a brittle bone disease, who are candidates for setrusumab.
• Patients suffering from Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD), the target for alvelestat.
• Patients with Autosomal Dominant Osteopetrosis Type 2 (ADO2) for vantictumab.

The fourth key customer segment involves external entities looking to acquire or partner on these late-stage assets:

• Large pharmaceutical and biotech companies seeking late-stage rare disease assets.

Here's a look at the estimated patient populations for the core indications, based on available data:

Disease Indication	Product Candidate	Geographic Scope	Estimated Patient Population
Osteogenesis Imperfecta (OI)	Setrusumab	U.S. and Europe	60,000 people
Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD)	Alvelestat	North America	Estimated 50,000 people with severe deficiency
Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD)	Alvelestat	Europe	Estimated 60,000 people with severe deficiency
Autosomal Dominant Osteopetrosis Type 2 (ADO2)	Vantictumab	Not specified	Data not available

For the segment of large pharmaceutical and biotech companies, Mereo BioPharma Group plc's financial position and pipeline maturity define the attractiveness of a potential transaction. The company's cash position as of September 30, 2025, was $48.7 million, with guidance to fund operations into 2027. This runway supports execution through key milestones, such as the expected final analyses for the setrusumab Phase 3 studies around the end of 2025. The company is actively advancing partnering discussions for alvelestat. The total ordinary shares issued as of September 30, 2025, stood at 795,484,404. The net loss for the third quarter ended September 30, 2025, was $7.0 million.

The customer segment seeking vantictumab is defined by the rare bone disease ADO2. Mereo BioPharma Group plc retained European commercial rights in a partnership deal with āshibio for this asset, following promising preclinical data presented at the 2025 ASBMR Annual Meeting.

The OI patient segment is being addressed through the setrusumab program, partnered with Ultragenyx, with final analyses for the Phase 3 Orbit and Cosmic studies expected around the end of 2025. The statistical threshold for success in the Orbit study was set at p<0.039.

For AATD-LD patients, alvelestat is being advanced, with the company finalizing start-up activities for a Phase 3 pivotal study, which is key to ongoing partnering processes. Alvelestat has Orphan Designation from both the EMA and the FDA.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Cost Structure

You're looking at the core expenditures driving Mereo BioPharma Group plc's operations as of late 2025. For a clinical-stage company, the cost structure is heavily weighted toward advancing its pipeline, meaning R&D is the dominant factor.

Heavy investment in Research and Development (R&D) for clinical trials represents a major cash outflow. For the three months ended September 30, 2025, total Research and Development expenses were reported at $4.3 million. This R&D spend is concentrated on key programs.

The cost structure includes significant spending tied to the setrusumab program, which is in Phase 3 trials. The R&D expenses for setrusumab specifically increased by $0.9 million in the third quarter of 2025 compared to the prior year period. Also contributing to R&D was alvelestat, with an increase of $0.5 million in Q3 2025 R&D expenses.

Manufacturing and supply costs for setrusumab, paid to Ultragenyx, are embedded within the R&D figures. The increase in R&D expenses for setrusumab during the third quarter of 2025 was primarily driven by amounts due under the manufacturing and supply agreement with the partner, Ultragenyx.

General and Administrative (G&A) expenses showed some cost control in the quarter. For the third quarter of 2025, General and Administrative expenses were $6.0 million. This was a decrease of $0.2 million compared to the third quarter of 2024, which the company attributed primarily to lower professional fees.

Regarding personnel costs for a lean team focused on R&D and business development, while the structure implies a focus on keeping headcount low, the specific dollar amount for personnel costs is not broken out separately from G&A or R&D in the provided data. However, the overall operating discipline is evident in the net loss figures.

The cumulative effect of these costs is reflected in the bottom line for the longer reporting period. The Net loss for the nine months ended September 30, 2025, was $34.53 million.

Here's a quick look at the key cost and loss metrics for the period:

Financial Metric	Period	Amount (USD)
General and Administrative Expenses	Three Months Ended September 30, 2025	$6.0 million
Total Research and Development Expenses	Three Months Ended September 30, 2025	$4.3 million
Net Loss	Nine Months Ended September 30, 2025	$34.53 million
Setrusumab R&D Expense Increase (YoY)	Three Months Ended September 30, 2025	$0.9 million

The company's cash position as of September 30, 2025, was $48.7 million, which management expected to support operations into 2027.

You can see the quarterly loss trajectory, which helps frame the burn rate:

• Net Loss for Q3 2025 was $7.0 million.
• Net Loss for Q3 2024 was $15.0 million.
• The Q3 2025 loss benefited from a foreign currency transaction gain of $1.9 million.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Revenue Streams

You're looking at how Mereo BioPharma Group plc brings in cash right now, late in 2025, which is heavily weighted toward development achievements rather than product sales, given the pipeline stage. Honestly, the revenue quality right now is non-recurring, which is typical for a clinical-stage company awaiting key data readouts.

The core of the current revenue recognition comes from the deals already struck, particularly the one with Ultragenyx for setrusumab, and the smaller licensing arrangements for non-core assets.

Here's a quick look at the financial components driving the top line:

Revenue Source Category	Specific Component/Asset	Reported/Potential Amount	Period/Status
Milestone Payments (Non-Core)	Leflutrozole Clinical Milestone	$0.5 million	Recognized in Q2 2025
Milestone Payments (Core)	Setrusumab Development Progress (Ultragenyx)	Up to $245 million potential	Contingent on future progress
Royalties (Future Sales)	Setrusumab Commercial Sales (Ultragenyx Territories)	Tiered Royalties	Contingent on commercial launch
Product Sales (Future)	Setrusumab EU/UK Commercial Sales	Analyst Estimate: $22.0 million for Q4 2025	Post-approval expectation
Total Recognized Revenue	Cumulative Sales to Date	$0.5 million	For the nine months ended September 30, 2025

You should note that for the third quarter ended September 30, 2025, Mereo BioPharma reported $0.0 million in revenue, as the Q2 figure was driven by that one-time milestone event.

The structure of the setrusumab partnership dictates how future cash flows will be split. It's important to track these potential payments as they are significant drivers for the company's non-dilutive funding potential.

The revenue streams are clearly segmented by asset and partner responsibility:

• Milestone payments from Ultragenyx for setrusumab development progress.
• Royalties on future commercial sales of setrusumab in Ultragenyx territories.
• Licensing revenue from non-core assets, exemplified by the $0.5 million milestone in Q2 2025 from leflutrozole.
• Future direct product sales in the EU/UK for setrusumab post-approval, where Mereo BioPharma Group plc has retained commercial rights.

To be fair, analyst models suggest that if the pipeline progresses as hoped, the full year 2025 sales estimate is $28.4 million, which would represent a major shift from the current run rate.

Finance: draft 13-week cash view by Friday.